Clinical trial · Interventional
A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
A PHASE 4, OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY OF INOTUZUMAB OZOGAMICIN IN CHINESE ADULT PATIENTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)
NCT05687032CI-TRIAL-00098357completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, single-arm, multicenter study in Chinese patients with relapsed or refractory CD22-positive B-cell ALL. The objective of the study is to confirm the efficacy, safety, and PK of inotuzumab ozogamicin in patients with relapsed or refractory B-cell ALL from mainland China.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| inotuzumab ozogamicin | Drug | Inotuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- inotuzumab ozogamicin
- description
- Dose: inotuzumab ozogamicin 0.8-0.5 mg/m\^2 IV, weekly, 3 times per cycle Cycle length: 21-28 days Total number of cycles: 6
- interventionNames
- Drug: inotuzumab ozogamicin
Primary outcomes (1)
- measure
- Percentage of Participants With Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) as Per Investigator's Assessment According to a Modified Cheson Criteria
- timeFrame
- From InO treatment initiation on Day 1 to CR or CRi (maximum up to 30.1 weeks of treatment exposure)
- description
- CR: disappearance of leukemia as indicated by \<5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) \>=1000 per microliter (/mcL) and platelets \>=100,000/mcL. C1 extramedullary disease (EMD) status was required (disappearance of all measurable and non-measurable EMD with the exception of lesions for which following must be true: participants with at least 1 measurable lesion, all nodal masses \>1.5 centimeter (cm) in greatest transverse diameter (GTD) at baseline regressed to \<=1.5 cm in GTD and nodal masses \>=1 cm and \<=1.5 cm in GTD at baseline must have regressed to \<1 cm GTD or reduced by 75% in sum of products of greatest diameters (SPD). No new lesions. Spleen and other previously enlarged organs must have regressed in size and must not be palpable. All diseases were assessed using the same technique as at baseline. CRi: CR except with ANC \<1000/mcL and/or platelets \<100,000/mcL.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female participants, age 18 years or older at screening. * Relapsed or refractory CD22-positive ALL. * Subjects with Philadelphia chromosome-positive (Ph+) ALL must have failed standard treatment with at least one tyrosine kinase inhibitor. * Patients in Salvage 1 with late relapse should be deemed poor candidates for reinduction with initial therapy. * Patients with lymphoblastic lymphoma and bone marrow involvement ≥5% lymphoblasts by morphologic assessment. * ECOG performance status 0-2. * Adequate renal and hepatic function, and negative pregnancy test for women of childbearing potential. Exclusion Criteria: * Subjects with isolated extramedullary relapse or active central nervous system (CNS) leukemia. * Prior allogeneic hematopoietic stem cell transplant (HSCT) or other anti-CD22 immunotherapy within 4 months, or active graft versus host disease (GvHD) at study entry. * Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS).
References
Publications (0)
Data not yet available
No reference posted for this study.